By: Dylan Sikes - AllPennyStocks.com News

Friday, May 30, 2014

There’s a lot of emphasis put on carbohydrates in maintaining a healthy lifestyle, but it’s carb control, not carb avoidance that is important. In fact, carbohydrates are the energy source of choice for the body, with experts recommending that about half of a person’s daily calorie intake come from carbs. For people living with diabetes, this can be a challenge because of a metabolic process that converts carbs into glucose. By definition, people with diabetes either can’t produce enough insulin, or properly use insulin they do have in their system, to breakdown the glucose, leading to high blood sugar levels that can be extremely unhealthy. Elevated blood sugar after a meal is relatively common in the diabetes community and often times not dangerous. High postprandial glucose levels can leave a person temporarily not feeling well, very tired or even can cause blurry vision. Repeated sugar spikes can be more serious in the long term as they can raise A1c levels, a key measure of diabetes control that correlates with increased risk of complications of diabetes, such as eye, heart, nerve and kidney disease.

To better manage glucose levels after meals, complex carbohydrate expert Boston Therapeutics, Inc. (OTCQB:BTHE) markets the caffeine-free chewable tablet Sugardown. Taken before a meal, Sugardown acts to minimize postprandial glucose by inhibiting enzymes that breakdown complex carbohydrates in the first place, meaning that there is not as much glucose available to be absorbed into the circulatory system.

In a similar fold, Boston Therapeutics is developing BTI-320, a non-systemic chewable drug candidate for the prevention of diabetes and its complications. The experimental drug is being evaluated in Phase 2 research as an enzyme inhibitor to reduce the amount of glucose available for absorption in the intestine. Earlier this month, the company signed an agreement with Patheon Inc. to manufacture BITI-320 tablets for an upcoming investigational new drug application with the Food and Drug Administration and planned international Phase 3 trial of the polysaccharide BTI-320 in 2015. With about 26 million Americans diagnosed with diabetes and associated healthcare costs in the hundreds of billions of dollars, diabetes represents one of the largest areas of unmet medical need today.

The preclinical section of the Boston Therapeutics pipeline includes Ipoxyn, an injectable anti-necrosis drug for treating lower leg ischemia associated with diabetes, and Oxyfex, a veterinary version on Ipoxyn.

Sales of Sugardown improved to $43,827 in the first quarter this year, compared to $23,336 in the same quarter of 2013, an increase of 88 percent. Last week, the company said that it penned a marketing agreement with Benchworks SD, a company that has worked with the likes of Pfizer (NYSE:PFE), Coca-Cola (NYSE:KO) and Shire (Nasdaq:SHPG), with the goal to drive brand awareness and grow Sugardown sales.

Benchworks may soon have some more arrows to put in their quiver to broaden awareness of the effectiveness of Sugardown for the nearly 100 million people in the pre-diabetic and diabetic population in the U.S. that are watching their glucose levels. On Thursday, Boston Therapeutics reported that it is initiating a Phase 2b trial for assessing the efficacy and safety of Sugardown in 24 Type 2 diabetes patients taking the commonly used diabetes drug metformin.

The double-blinded study, to be conducted by Accumed Research Associates in Garden City, New Jersey, will take five weeks to complete. Data will be collected to evaluate postprandial glucose in patients receiving Sugardown plus metformin compared to patients only receiving metformin. The primary endpoint is postprandial serum glucose area under the curve. Secondary endpoints are peak postprandial serum glucose, time to peak postprandial serum glucose, and peak blood serum excursion at two hours from baseline.

"We expect this study will strengthen the existing body of evidence that Sugardown can play a useful role in supporting healthy blood sugar levels,” said Dr. David Platt, chief executive at Boston Therapeutics, in a prepared statement today.

Shares of BTHE have fluctuated a lot in the past year, taking a dip as low as 15 cents on an intraday drop last August and climbing as high as $1.67 at the start of 2014. Shares have been trading sideways in the area of $0.60 - $0.70 throughout most of May and are not really responding to the new trial of Sugardown since Thursday’s announcement. Investors will likely be paying attention to the brief trial as some positive data could easily provide a catalyst for the stock to break out of its current range. Proper due diligence is, as always, encouraged.

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